Journal of Clinical and Cellular Immunology
Open Access
ISSN: 2155-9899
ISSN: 2155-9899
Girish S Naik
Biocon Research Limited, India
Posters-Accepted Abstracts: J Clin Cell Immunol
Background: Itolizumab, an anti-CD 6 monoclonal antibody downregulates Th1 and Th17 pathway. Twenty eight week results from a double-blind, placebo controlled, phase-3 trial of itolizumab was reported previously in 225 moderate-to-severe plaque psoriasis patients demonstrating safety and efficacy. Objective: To determine the long term efficacy of itolizumab and effect on quality of life during the randomized withdrawal phase. Methods: At week 28, patients with PASIâ?¥75 were re-randomized to placebo (group 1P; n=39) or itolizumab (group 1M; n=40). Partial responders (PASIâ?¥50 but <75) were switched to open-label itolizumab (group 2; n=59). Group 3 (n=39) remained on itolizumab irrespective of PASI at week 28. Results: In group 1P 52.5% maintained PASIâ?¥75 and 70% maintained PASIâ?¥50 at week 52. Groups 1M and 3 had higher responses (66.7% and 84.6%). Over 50% of the partial responders at week 28 achieved a late PASIâ?¥75 response at week 52. At week 28, mean DLQI (Dermatology Life Quality Index) scores were >4 across all groups and this improvement was maintained across all groups at week 52 with group 2 showing maximum improvement (10.2% at week 28 reported â??no impact of diseaseâ? on QoL compared to 27.6% at week 52). In group 2, the physical component scale and mental component scale of SF-36 improved by 1.3 and 1.6 points at week 52. There was no significant difference in the scores for the other groups from week 28 to 52. Conclusions: Itolizumab produces long term remission and sustains improved quality of life for both physical and mental components.
Email: girgray@gmail.com